FDA EIR - Fan Z. Caprio, M.D. - June 14, 2019

An FDA inspection of Clinical Investigator Fan Z. Caprio, M.D., located at Northwestern Medicine in Chicago, was conducted from June 10-14, 2019. This for-cause inspection, initiated by a complaint, reviewed the investigator's adherence to regulatory requirements under the Bioresearch Monitoring Compliance Program (CP 7348.811) for human drug studies.The inspection identified two primary objectionable conditions, documented on an FDA-483. First, Dr. Caprio failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan (21 CFR 312.60). This was primarily due to a lack of oversight, exemplified by a non-compliant study subject continuing to receive investigational medication for an extended period without proper intervention or sponsor notification. Second, there was a failure to prepare and maintain adequate and accurate case histories (21 CFR 312.62(b)). This resulted in significant delays, some exceeding a year, in reporting serious adverse events (SAEs) to the sponsor, as critical medical information was not consistently captured in study documentation. The institutional review board (IRB) had also previously cited serious non-compliance and requested a corrective action plan.During the close-out meeting, Dr. Caprio acknowledged the observations. Discussions emphasized the need for enhanced oversight of clinical trials under her direction and the implementation of documentation practices consistent with good clinical practice. She committed to providing a timely response to the FDA-483.